Doctors Concerned About The Patenting Of Basic Science

from the seems-like-a-pretty-serious-problem dept

Joe Mullin has another excellent article looking at an important ongoing patent lawsuit, Prometheus Laboratories v. Mayo Collaborative Services, which looks at whether or not certain medical tests can be patented. As Mullin notes, it's a situation where patent system believers find themselves diametrically opposed to doctors, who feel patents on such things are a serious problem and harming patient health. Once again, what you see is a single entity trying to block out competition in an effort to gain monopoly rents, even if people are harmed in the process by not being able to get or afford important medical tests. And the biggest concern (especially among medical professionals) is the idea that you can patent counting something that occurs in nature:

"The patents are based on observations of the laws of nature," says David Herbert, chief administrative officer for Mayo Medical Laboratories. "We chose to make a stand." Such "observational" patents increase costs, slow innovation, and worsen patient care, he says. "It doesn't allow the test to be performed close to the bedside, and there's no ability to have second opinions."

The lawsuit is in the appeals court right now -- with a current ruling that the patents aren't valid for merely observing nature, though an earlier summary judgment found the other way. Still, this isn't just some random discussion on patents and copying. Lives are at stake, and doctors are pissed off at the ridiculousness of the situation:

"Physicians have longstanding obligations to advance and share useful medical knowledge with patients and physicians." Patents on basic scientific principles "threaten to stifle innovation and raise the costs of medical treatment." And claiming exclusive rights to "scientific facts," such as the correlation that Prometheus purports to own, actually harms research and personalized medicine rather than helping it, the doctors argue.

Hopefully the court realizes how dangerous such patents are for society (beyond just being ridiculous) and rejects them.

Broken record

I know I seem to say this same thing whenever a medical patent story comes out, but I am REALLY confident that you will see this work out in favor of whatever side the medical BUSINESSMEN are on.

If EVER there was an industry fully indoctrinated into the Rockefeller family's will and interest, it is the medical and pharam industry. A simple recounting of the boards their reps sit in on, the financial donations they've made to certain schools/lobbying groups/etc., and their indirect ownership of pharma companies ought to suffice for reasonable evidence.

Re: Broken record

Well, most potential businessmen would be severely harmed by these restrictions; it is specifically incumbents that benefit from patents. But of course, they have the most money and influence to buy off the FDA and other government regulators/legislators, as well as the most immediate desire to do so, so we get decisions that are harmful to businesses that might desire to enter the market. For whatever reason though, plenty of us still apparently believe that tthe large players should be allowed to stockpile all the patents they want and this will somehow be good for consumers...

I wonder how many of these tests would work without the pile of money that was spent to reasearch and create them. I don't think we are talking about a patent on blood pressure readings or anything like that, but rather on things like complex testing kits, meg resonance machines, etc.

It's easy to say "don't patent them", and then it is just as easy for a company to make a cheap knock off. The problem is that without the initial research (that cost money) there is nothing to knock off.

The other thing is that there is talk like there is a patent and thus there is no problem, which couldn't be further from the truth. Medical testing supply companies desperately want to put the product out there, they want to make their investment back and make a profit over time. What's the problem?

Re:

What about the money? Saying they need to recoup their costs of R&D is like saying the big-box retail outlets need to recoup the cost of installing shelves. That may be true but it has no bearing on how much I'm willing to pay for the widget in the window.

If it's test kits and imaging machines being talked about, then patent those, and let someone else patent a different sensor that looks for the same thing. That's what patents are for, patenting a better mousetrap. But these guys seem to want to patent "counting metachlorians" and not the test kit that does it. That's the sort of anti-competitive practice that slows down the market and, in this case, may cost people their health.

Re:

"I wonder how many of these tests would work without the pile of money that was spent to reasearch and create them. I don't think we are talking about a patent on blood pressure readings or anything like that, but rather on things like complex testing kits, meg resonance machines, etc."

When you talk about this stuff on the large scale of the medical industry and the pharma industry, this idea that these companies need to recoup costs associated with R&D is ridiculous.

To Quote Dr. Marcia Angell, former Editor in Chief of the New England Journal of Medicine, she stated that the medical industry's "expenditures for R&D, while large, were consistently far less than profits. For the top 10 companies, they amounted to only 11% of sales in 1990, rising slightly to 14% in 2000. The biggest single item in the budget is...something usually called 'marketing & administration'--a name that varies slightly from company to company. 1996...36% of sales revenue went into this category. Note that this is two and a half times the expenditures for R&D."

Add to that the recent reversal of United States policy on what is referred to as "direct to consumer" pharma advertising, and you've got a recipe for an industry perpetuating its own bloat through bought politicians and corruption.

But seriously, that's more than enough w/the "recoup their costs" bullshit. Repeat it to the sheep that don't know any better (since they're probably so jacked up on Ritalin, aspartame, Sodium Fluoride, and Valium that they don't know any better).

observing laws on nature

Prometheus funded the research necessary to determine the metabolite levels that coincide with patient's clinical response to thiopurine drugs 10 years ago when this was patented! No one knew why 1/2 the patients taking Thiopurines would get sick from leucopenia or not respond until Prometheus educated the world with their data. Mayo's lawyers argue that this is common knowledge... it is now, because Prometheus told you over 10 years ago. Mayo duplicated and tried to sell their own version of this metabolite test... and Prometheus sued them. I agree with them 100% If this type of work can be protected with patents, good luck with the future of diagnostic medicine. Maybe we can open source all medicine, and sell lemonaid and car wash fundraisers for research capital ;)

The claims could be considered obvious under the patent statute if one were to consider the "determining clauses" as being "descriptive, non-functional". However, the courts have been busy recently deciding appeals on what subject matter is considered statutory under 35 USC 101.

one more thing

By the way, this case does not deal with, as mike put it, "things that occur in nature". That is a gross simplification of claim limitations that deal with the intangible. Nonetheless, it is nothing like patenting a flower you picked in your yard.

Re: business priority

Re:

It's easy to say "don't patent them", and then it is just as easy for a company to make a cheap knock off. The problem is that without the initial research (that cost money) there is nothing to knock off.

I'm sure that knowing this will be a great comfort to all the people who can't afford to get the tests they need because there's no "cheap knock off".

Re: Re:

"I'm sure that knowing this will be a great comfort to all the people who can't afford to get the tests they need because there's no "cheap knock off"."

Would it be any better comfort to them that there is no test available, because nobody could afford to create it? After all, without the initial investment made to create the methods and processes to do the testing and to actually accurate test, there would be nothing to "knock off".

Haha

"Would it be any better comfort to them that there is no test available, because nobody could afford to create it? After all, without the initial investment made to create the methods and processes to do the testing and to actually accurate test, there would be nothing to "knock off"."

Hahahahahaha. good one! very funny. You had me going. The idea that without patent protection NOTHING would get created....snort....I'm still laughing! you really know how to knock 'em dead.

See, mankind has been creating since, well, ever, and for thousands of years no one had or needed patent protection in order to create/research/invent anything.

a single entity trying to block out competition in an effort to gain monopoly rents

hey genius... that's the idea of a patent. if people might get screwed for 20 years so everyone else FOR THE REST OF FOREVER can exploit a technology or process, that's a price we're willing to pay.

what's even funnier is that every time you bitch about medical patents, you fail to mention what happened in cipro, and every one of the hatch waxman para4 lawsuits. you're bitching about a hole when you have no clue how deep it is.

Patents aren't a right

I have a few things to say on this subject. First, I am a capitalist through and through. I also think the less the government is involved in something, the better it works out for pretty much everyone.

Patents and patenting are not a right. They are not an inherent aspect of any economic system. They are a government granted monopoly. This alone makes them an attack on freedom. Some attacks on freedom are good. The government takes away my freedom to kill you, and your freedom to kill me. That's a good thing (morals should do it as well, but you can't have everything). Most are very very bad.

Not only that, but there are some severe ethical and moral issues where patenting medical advances is concerned. Everyone knows of the hippocratic oath (both old and new versions), but there is also the Declaration of Geneva to consider. Particularly these declarations:

I solemnly pledge to consecrate my life to the service of humanity;
I will give to my teachers the respect and gratitude that is their due;
I will practise my profession with conscience and dignity;
The health of my patient will be my first consideration;

Capped off with
I make these promises solemnly, freely and upon my honour.

Suffice to say, after reviewing those, the morality of restricting a medical test to a centralized facility without review or opportunity for another medical opinion comes into question loud and clear (at least to me).

As far as the economic side of the equation here, R&D for pharmaceuticals is regulated to the point of strangulation. The U.S. has some of the most ridiculous amounts of bureaucratic bull to get a drug developed, tested, and approved that it significantly increases the cost of development.

Add on top of that the unethical actions of some (not all) pharma companies, e.g. slightly modifying a drug (adding a blood pressure medication and an antacid together) prior to patent expiration to repatent the same drug under a different name to maximize the cashflow. Oh, and they do collude with unethical physicians to push these new non-generics out on the market ahead of the now generic versions that still accomplish the primary purpose.

Now unfortunately the judge isn't going to be ruling on these grounds. If he's doing his job, he's merely ruling on the legality of the patents and if they are appropriately awarded under current patent law. With patent law as messed up as it is right now, I can see this coming to an eventual bad conclusion.

There's a lot of problems right now in the industry, and patents are only a small part, but they are an important part and it needs to be fixed badly. Seriously...they aren't even just patenting the testing equipment they developed. They are patenting the results of basic scientific operation. Imagine if Faraday patented his observations which were just basic science. We wouldn't have microwaves let alone the internet. Einstein (who at one point in time was a patent clerk!) didn't need to patent his observations and thoughts on the functions of the universe and influenced scientific development in ways we still can't even fathom.

Patents do not protect the progress of science, period. It's good to make money from your work and to profit from it, but once the information is out there, you can't stop it. When it comes to medical information, information that can save lives, it's almost criminal, and certainly unethical.

Re:

hey genius... that's the idea of a patent. if people might get screwed for 20 years so everyone else FOR THE REST OF FOREVER can exploit a technology or process, that's a price we're willing to pay.

If there were evidence that after 20 years everyone was better off you'd have a point. But the evidence suggests the opposite: that patent *retard* the pace of innovation so that after 20 years people are *worse* off than they would have been earlier.

So, I believe your name more aptly applies to yourself (yet again -- it's becoming a pattern, actually).

Still waiting for the legalized snake oil salesmen

So how long before some company comes up with a test and cure for some unknown potentially serious condition (FUBAR as an example) that doesn't really exist. All the pieces are there and have been used for various purposes.

1. Have bogus 'Journal' publish papers on the seriousness of FUBAR and the wonderful 'cure' developed by company X.
2. Company X produces bogus test for FUBAR that randomly returns 33% positive result.
3. Company X produces and sells 'cure' for FUBAR to the ignorant sheeple (tm).
4. ....
5. Profit

And since it's all patented nobody else can reliably reproduce or refute the results without a patent infringement suit.

My tinfoil hat got a little crushed when wife used it to wrap up the leftovers last night, so I'm using a Wax Paper one today, but it's just not the same.....

Re: Re: Re:

My friend has no medical insurance and is slowly going broke from buying the expensive heart medication he needs to stay alive. He can't buy a generic version because the drug company has a patent on it and won't allow generics to be made for a certain number of years.

So he has a choice between going broke or having potentially fatal heart problems. But hey, as long as the drug company gets the money they feel they're entitled to, that's all that matters, right?

Re: Still waiting for the legalized snake oil salesmen

Hey, tinfoil hat not needed. This has already begun.

Ever see the ads on TV for male enhancement? Yeah, I thought so. How about restless leg syndrome ... there are many others, and guess what - they already have a cure. All you need to do is pick up the phone, have your credit card ready and you too will soon be enjoying the many benefits of [fill in the blank] wonderful product.